Activated-Potentiated Form
Medicaments prepared according to homeopathic techniques include those prepared by homeopathic potentiation, also referred to as activation, through multiple consecutive dilutions in a carrier (water or water-alcohol solvent)—thereby decreasing concentration—in combination with shaking of each consecutive dilution. See, e.g., RU 2191601 C1; RU 2192888 C1; RU 2332236 C1 (English version found at EP 2 123 300); and RU 2438707 C2 (U.S. Pat. Pub. 2011/0008452). The result of preparation by homeopathic potentiation is a medicament which contains low or ultra-low doses of initial medicament; dilution may proceed to approximate or exceed 1 mole of carrier per molecule of the initial medicament in molecular form, keeping in mind the total number of molecules per mole is given by Avogadro's number (6.022×1023 mol−1). The term molecular form is further defined below. In the context of a solid, dilution is referred to as trituration. Through homeopathic techniques the carrier may acquire modifying potency, manifested in its ability to alter physical, chemical and/or biological properties of the starting substance when treated by the said activated-potentiated form (RU 2161955 C1).
The term “molecular form” is used to denote one or more molecules of a particular chemical substance. Thus, the molecular form of aspirin can be a single molecule of acetylsalicylic acid; 1 mole of aspirin in molecular form consists of 6.022×1023 molecules of acetylsalicylic acid and weighs 180.157 grams.
The term “activated-potentiated form” is used to denote a product of homeopathic potentization of an initial solution containing a molecular form of a substance. In other words, a solution containing the molecular form of a substance, e.g., a specific antibody or organic molecule, is subjected to repeated consecutive dilution and multiple vertical shaking of each obtained solution in accordance with homeopathic techniques. The preferred diluent, often called the carrier, is water or a water-ethyl alcohol mixture. The preferred concentration of the molecular form in the initial carrier ranges from about 0.5 to about 5.0 mg/ml. The activated-potentiated form may be prepared from an initial solution by homeopathic potentization, preferably using the method of proportional concentration decrease by serial dilution of 1 part of each preceding solution. Thus, 1 part of the initial solution is mixed with 99 parts (for centesimal dilution) of the carrier and subjected to external impact. Preferably, the external impact involves multiple vertical shaking (dynamization) of each dilution. This results in the creation of the 1st centesimal dilution, denoted C1. The 2nd centesimal dilution (C2) is prepared by mixing 1 part of the 1st centesimal dilution C1 with 99 parts of the carrier. This procedure is repeated 10 additional times to prepare the 12th centesimal dilution C12. Separate containers are typically used for each subsequent dilution up to the required dilution factor. Similar procedures with the relevant dilution factor are performed to obtain, for example, dilutions C30, C50 and C200. This method is well-accepted in the homeopathic art. See, e.g. V. Schwabe “Homeopathic medicines”, M., 1967, p. 14-29, incorporated herein by reference for the purpose stated. C12, C30, and C200 represent dilutions of the primary matrix solution (mother tincture) of antibodies 10012, 10030 and 100200 times, respectively.
Preferred activated-potentiated forms are often a mixture of several centesimal dilutions of the same molecular form. For example, a mixture of C12, C30, and C50 dilutions or C12, C30 and C200 dilutions. When using the mixture of various homeopathic dilutions each component of the composition, e.g., C12, C30, C50, C200, is prepared separately according to the above-described procedure until the next-to-last dilution is obtained, i.e., until C11, C29, and C199 respectively, and then one part of each component is added in one container according to the mixture composition and mixed with the required quantity of the carrier, i.e., 97 parts for centesimal dilution.
Examples of homeopathic potentization are described in U.S. Pat. Nos. 7,572,441 and 7,582,294, which are incorporated herein by reference in their entirety and for the purpose stated. The term “activated-potentiated form” and the term “ultra-low doses” are meant as fully supportive and primarily synonymous with one another.
Homeopathic Bipathy
U.S. Pat. No. 8,178,498 describes the concept of bipathic medicinal forms. Bipathic medicinal preparations combine therapeutic values of a medicinal substance in therapeutic dose and an activiated-potentiated preparation chemically homogeneous with the medicinal substance but different in mechanism of action on the organism. Put another way, the described bipathic medicinal preparation combines the molecular form of a medicinal substance in approximately its standard concentration and an activiated-potentiated form derived from the same molecular form but having its molecular form present, if at all, in ultra-low concentration. The standard dose and activated-potentiated form, either combined or administered approximately simultaneously, are shown to promote biological activation and induce positive morphological and functional changes in the form of “systemic adaptation” responsible for increased therapeutic efficiency of the active medicinal substance with reduced risk of patients' individual reactions and undesirable adverse side-effects or after-effects.
Moreover, “bipathic” simultaneous administration of medicinal substance in therapeutic dose and activated-potentiated form, according to U.S. Pat. No. 8,178,498: (1) allows for lower conventional doses of the substance, (2) prevents habituation due to enzyme “induction”, and (3) prevents overdosage owing to neutralization of negative energies and stimulation of certain organs and of the whole. U.S. Pat. No. 8,178,498 is incorporated herein by reference in its entirety and for the purpose stated.
Qualitative/Quantitative Assessment of Medicaments
Known in the art, e.g., RU 2181890 C1, is a method to determine the biological activity of a substance. The activity is represented by a ratio between the rate of enzymatic response to a test sample before and after adding a substance. An “optimal substance concentration in a sample” is determined in vitro. This method is not suitable, however, for determining the potency of medicaments prepared according to homeopathic techniques.
Known in the art is the method of determining homeopathic medicament potency by applying linearly polarized coherent optical radiation to an activated medicament present in a constant magnetic field. Scattered transmitted radiation is measured using time-related accumulation of values of its polarized component intensity in the mode of optical bias from different points of test medium. Analysis is conducted to calculate frequency spectrum of ultra low fluctuations of transmitted intensity and data is compared with a standard specimen. See, e.g., RU 2112976 C1.
Also known is the method for qualitative determination of homeopathic medicine or activated-potentiated form. The method includes treating a test medium with a standard specimen and registration of alterations of physical and chemical parameters. A set of known substances are used which structure and/or composition are approximately similar or similar to the ones of the determined homeopathic medicine or to the ones of potentiated substance form as well as structure and/or composition of antibodies to these known substances. Identification of homeopathic medicine or potentiated substance form shall be based on the known substance, which reaction with the appropriate antibody when homeopathic medicine or potentiated substance form are introduced into reaction medium is accompanied by alterations registered using immunochemical analytical methods based on antigen-antibody reaction (RU 2195648 C2).
The prior art methods do not, however, provide reliable and reproducible qualitative and quantitative determination of drug identity and potency associated with an activated-potentiated form. This includes activated medicaments prepared according to homeopathic techniques described above.